Minimally invasive versus convencional surgery for the treatment of displaced fractures of the clavicle shaft: a randomized multicentric pragmatic clinical trial

MIO vs ORIF in the treatment of displaced fractures of the clavicle shaft: a randomized multicentric pragmatic clinical trial - BRICS BRICS – Brazilian Multicentric Pragmatic Randomized Trial of Surgical Interventions for displaced Diaphyseal Clavicle Fracture Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-3czz68

Enrollment

Unknown

Registered

2020-11-03

Start date

2021-07-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clavicle fracture

Interventions

Experimental group: 95 patients will be submitted to minimally invasive osteosynthesis of displaced fracture of the diaphysis of the clavicle, using non locking reconstruction plate in a superior posi

Q65.070

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: healthy volunteers; both genders; age over 18 years; with displaced fractures of the shaft of the clavicle type 2B according to Robinson's classification; evolution of up to 21 days.

Exclusion criteria

Exclusion criteria: patients with open fractures of the clavicle; with associated vascular or nerve injuries; with fractures of the shaft of the clavicle with joint extension; with concomitant fractures or dislocations in the shoulder girdle; with other fractures in the same upper limb; with a history of previous fractures in the clavicle; with a history of previous trauma to the shoulder girdle; with pathological fractures; patients with metabolic diseases; patients with congenital deformities on the same limb

Design outcomes

Primary

Measure	Time frame
Assess the number of complications of each technique. Complications will be considered cases of superficial or deep infection, hypertrophic scarring, pseudoarthrosis, refracture, implant failure, skin irritation and shoulder pain, except for hypoesthesia. The number of complications is a discrete numerical variable whose values will be accounted for in a twelve-month postoperative follow-up period.;Evaluate the number of re-operations for each technique. Re-operations will be considered for cases that require a new surgical intervention such as deep infection, pseudoarthrosis, refracture, implant failure and scheduled implant removal. The number of re-operations is a discrete numerical variable whose values will be accounted for in a twelve-month period of postoperative follow-up.	—

Measure

Time frame

Assess the number of complications of each technique. Complications will be considered cases of superficial or deep infection, hypertrophic scarring, pseudoarthrosis, refracture, implant failure, skin irritation and shoulder pain, except for hypoesthesia. The number of complications is a discrete numerical variable whose values will be accounted for in a twelve-month postoperative follow-up period.;Evaluate the number of re-operations for each technique. Re-operations will be considered for cases that require a new surgical intervention such as deep infection, pseudoarthrosis, refracture, implant failure and scheduled implant removal. The number of re-operations is a discrete numerical variable whose values will be accounted for in a twelve-month period of postoperative follow-up.

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Secondary

Measure	Time frame
Pain assessment using the visual analogic scale (VAS). The questionnaire will be applied by an examiner blinded to the surgical procedure, with a patient wearing clothing (T-shirt), which will cover the incision and allow movements of the evaluation. The score is a continuous numeric variable that will be measured at 45, 180 and 360 days. The absolute difference and percentage of values between the periods for each participant and between experimental and control groups will be evaluated.;Quality od Life assessment using the SF-12 scale. The questionnaire will be applied by an examiner blinded to the surgical procedure, with a patient wearing clothing (T-shirt), which will cover the incision and allow movements of the evaluation. The score is a continuous numeric variable that will be measured at 45, 180 and 360 days. The absolute difference and percentage of values between the periods for each participant and between experimental and control groups will be evaluated.;Functional assessment using the DASH score. The questionnaire will be applied by an examiner blinded to the surgical procedure, with a patient wearing clothing (T-shirt), which will cover the incision and allow movements of the evaluation. The score is a continuous numeric variable that will be measured at 45, 180 and 360 days. The absolute difference and percentage of values between the periods for each participant and between experimental and control groups will be evaluated.;Functional assessment using the Constant score. The questionnaire will be applied by an examiner blinded to the surgical procedure, with a patient wearing clothing (T-shirt), which will cover the incision and allow movements of the evaluation. The score is a continuous numeric variable that will be measured at 45, 180 and 360 days. The absolute difference and percentage of values between the periods for each participant and between experimental and control groups will be evaluated.;Clinical evaluation with shoulder range of moti	—

Measure

Time frame

Pain assessment using the visual analogic scale (VAS). The questionnaire will be applied by an examiner blinded to the surgical procedure, with a patient wearing clothing (T-shirt), which will cover the incision and allow movements of the evaluation. The score is a continuous numeric variable that will be measured at 45, 180 and 360 days. The absolute difference and percentage of values between the periods for each participant and between experimental and control groups will be evaluated.;Quality od Life assessment using the SF-12 scale. The questionnaire will be applied by an examiner blinded to the surgical procedure, with a patient wearing clothing (T-shirt), which will cover the incision and allow movements of the evaluation. The score is a continuous numeric variable that will be measured at 45, 180 and 360 days. The absolute difference and percentage of values between the periods for each participant and between experimental and control groups will be evaluated.;Functional assessment using the DASH score. The questionnaire will be applied by an examiner blinded to the surgical procedure, with a patient wearing clothing (T-shirt), which will cover the incision and allow movements of the evaluation. The score is a continuous numeric variable that will be measured at 45, 180 and 360 days. The absolute difference and percentage of values between the periods for each participant and between experimental and control groups will be evaluated.;Functional assessment using the Constant score. The questionnaire will be applied by an examiner blinded to the surgical procedure, with a patient wearing clothing (T-shirt), which will cover the incision and allow movements of the evaluation. The score is a continuous numeric variable that will be measured at 45, 180 and 360 days. The absolute difference and percentage of values between the periods for each participant and between experimental and control groups will be evaluated.;Clinical evaluation with shoulder range of moti

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Countries

Brazil

Contacts

Public ContactAdriano;Marcel Mendes Jr;Tamaoki

Hospital Universitário da Universidade Federal de Juiz de Fora;DOT - DEPARTAMENTO DE ORTOPEDIA UNIFESP

adrianofmjr@yahoo.com.br;marceltamaoki@gmail.com+5532985104433;+551155764848

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 14, 2026